Deaf Children1OL1NCT06914531
Assessment of the Development of Social Cognition in a Deaf Child With a Cochlear Implant : A Study Using a Standardized Questionnaire
An observational study of Deaf Children and Cochlear Implant, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study investigates the adaptability of a questionnaire assessing social cognition in children with cochlear implants aged 3 to 6 years, implanted before the age of 15 months. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Deaf Children, Cochlear Implant
- What is being tested?
- Questionnaire comprehension test
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2025to 3 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of children aged 3 to 6 years with congenital severe-to-profound deafness who received a cochlear implant before 15 months of age.
Who may be able to join
- Children aged 3 to 6 years old, who received a cochlear implant before the age of 15 months, who use their implant(s) and have a supportive family environment,
- Children with at least one cochlear implant undergoing speech therapy and are being monitored by the Pediatric Cochlear Implant Unit at Toulouse University Hospital,
- Children who are able to communicate: through speech, gestures, or French Sign Language,
- Children and their family whose mother tongue is French, - Social security coverage.
Who cannot join
- Cognitive or psychological impairment preventing the child from communicating,
- Other sensory or motor deficits that may interfere with pointing,
- Unstable psychiatric illness,
- Child whose parents both benefit from a legal protection measure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Toulouse - Pierre Paul Riquet
Toulouse, 31059
Marie-Noelle Calmels, +33 (0)5 61 77 90 09 ext. 33, calmels.mn@chu-toulouse.fr
Marie-Noelle Calmels
About this study
This study investigates the adaptability of a questionnaire assessing social cognition in children with cochlear implants aged 3 to 6 years, implanted before the age of 15 months. The primary objective is to evaluate the comprehensibility and relevance of the questionnaire in this population, considering their specific communication modes and cognitive profiles. By analysing response variability, communication abilities, and social interaction patterns, the study aims to refine the tool for accurate assessment. The findings will contribute to improving evaluation methods for social cognition in young deaf children.
Read the detailed description
- Scientific Justification: Social cognition, particularly Theory of Mind, plays a crucial role in children's social interactions and emotional development. However, deaf children, especially those with cochlear implants, may experience delays or differences in Theory of Mind development due to limited access to spoken language and incidental learning. Assessing their social cognitive abilities requires tailored tools that accommodate their unique communication modes. This study aims to evaluate the adaptability and validity of a questionnaire designed to assess social cognition in deaf children aged 3 to 6 with cochlear implants. By analyzing communication strategies, response variability, and social interaction patterns, the research seeks to refine assessment methods, ensuring they accurately capture these children's cognitive and social competencies.
- The content of the responses: it is essential to measure this because it enables us to assess the quality of the children's reflections. Response content provides valuable insights into how deaf children with cochlear implants before 15 months perceive and interpret social interactions. This will allow us to test whether deaf children develop similar or different strategies for understanding the social world. Rich and relevant content would indicate good integration of social skills, which would be an indicator of success for the study.
- Understanding their own answers: it is important to check that the children understand what they are answering. This criterion is important because it ensures that the answers given are not the result of chance or a desirability bias, but of genuine reflection and a real understanding of social concepts. A child's understanding of his or her own responses is indicative of cognitive maturity and the ability to apply knowledge in social contexts, which is a central objective of the study.
- The degree of response, the completeness and accuracy of the answers given, is a key indicator of children's ability to understand and engage in cognitive tasks. This criterion measures the commitment and mental effort invested by the child in the exercise, as well as his or her ability to formulate detailed and relevant answers. A high level of response would be a positive sign of successful cochlear implantation in terms of cognitive and social development, while a low level of response could suggest difficulties in processing social information or expressing thoughts coherently.
- Conditions
- Deaf Children, Cochlear Implant
- Being tested
- Questionnaire comprehension test
- Keywords
- children, Cochlear Implants, Deafness, Social cognitive skills, Emotions skills
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire comprehension testOther
Participants will complete a standardized questionnaire assessing social cognition, adapted for cochlear-implanted children aged 3 to 6 years. The assessment includes the Item Scale and the Test of Emotions Comprehension adapted and mixed together. The questionnaire evaluates children's ability to understand emotions, social interactions, and cognitive perspective-taking. Each child will complete the test in a single session lasting approximately 20 minutes, under the supervision of a trained investigator, with an orthophonist and a parent present
| Study group | Role | What they receive |
|---|---|---|
| deaf child with a cochlear implant | This study focuses on children aged 3 to 6 years with congenital severe-to-profound deafness who received a cochlear implant before 15 months of age. The research aims to assess the adaptability of a standardized questionnaire evaluating social cognition in this population. Their communication abilities, response variability, and social interaction patterns are analyzed to refine assessment tools. Receives: Other: Questionnaire comprehension test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rate of Standardized Social Cognition Questionnaire
The primary outcome measure is the proportion of children who successfully complete all items of the standardized social cognition questionnaire. Success is determined by the child's ability to understand and respond coherently to the questions, demonstrating engagement and cognitive processing related to social interactions and emotions.
Measured: Assessed during a single study visit (approximately 20-minute session).
Secondary outcomes (4)
Communication Ability During Questionnaire Completion
Evaluation of the participant's ability to communicate while completing the questionnaire, including composite criterion with verbal, non-verbal (gestures, facial expressions), and mixed communication strategies. This will help assess whether children can effectively engage with the assessment.
Measured: Assessed during a single study visit (approximately 20-minute session)
Variability of Responses Among Participants
Analysis of differences in questionnaire responses among participants. Variability will be examined based on factors such as age, duration of cochlear implant use, and language proficiency to determine individual differences in social cognition development.
Measured: Assessed during a single study visit (approximately 20-minute session).
Homogeneity of Responses Within the Study Group
Assessment of response consistency across participants. Identifying patterns of similarity in answers will provide insight into shared cognitive and social processing abilities in cochlear-implanted children. High homogeneity could indicate a common understanding of the instructions and uniform accessibility of the questionnaire. Conversely, marked heterogeneity could reveal differences in the cognitive strategies used or in the interpretation of the items, requiring adaptation of the questionnaire.
Measured: Assessed during a single study visit (approximately 20-minute session).
Identification of Social Skills Demonstrated During the Assessment
Observation and analysis of social behaviors exhibited by participants during the questionnaire session. This is a composite criterion who includes joint attention, emotional regulation, and perspective-taking, providing insight into their social cognitive abilities.
Measured: Assessed during a single study visit (approximately 20-minute session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start31 Mar 2025 (estimated)
- Primary completion3 Mar 2026 (estimated)
- Study completion3 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deaf ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914531
- Sponsor's protocol ID
- RC31/25/0073
- Other IDs
- ID-RCB : 2025-A00479-40
- Acronym
- 1OL1
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fulcher A, Purcell AA, Baker E, Munro N. Listen up: children with early identified hearing loss achieve age-appropriate speech/language outcomes by 3 years-of-age. Int J Pediatr Otorhinolaryngol. 2012 Dec;76(12):1785-94. doi: 10.1016/j.ijporl.2012.09.001. Epub 2012 Oct 17.
PubMed 23084781De Giacomo A, Craig F, D'Elia A, Giagnotti F, Matera E, Quaranta N. Children with cochlear implants: cognitive skills, adaptive behaviors, social and emotional skills. Int J Pediatr Otorhinolaryngol. 2013 Dec;77(12):1975-9. doi: 10.1016/j.ijporl.2013.09.015.
PubMed 24466572Allen MC, Nikolopoulos TP, O'Donoghue GM. Speech intelligibility in children after cochlear implantation. Am J Otol. 1998 Nov;19(6):742-6.
PubMed 9831147
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Development of Social Cognition in a Deaf Child With a Cochlear Implant : A Study Using a Standardized Questionnaire
- ClinicalTrials.gov ID
- NCT06914531
- Acronym / sponsor ID
- 1OL1 / RC31/25/0073
- Conditions
- Deaf Children, Cochlear Implant
- Keywords
- children, Cochlear Implants, Deafness, Social cognitive skills, Emotions skills
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 3 Mar 2026 (estimated)
- Study completion
- 3 Mar 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the adaptability of a questionnaire assessing social cognition in children with cochlear implants aged 3 to 6 years, implanted before the age of 15 months. The primary objective is to evaluate the comprehensibility and relevance of the questionnaire in this population, considering their specific communication modes and cognitive profiles. By analysing response variability, communication abilities, and social interaction patterns, the study aims to refine the tool for accurate assessment. The findings will contribute to improving evaluation methods for social cognition in young deaf children.
Detailed description
- Scientific Justification: Social cognition, particularly Theory of Mind, plays a crucial role in children's social interactions and emotional development. However, deaf children, especially those with cochlear implants, may experience delays or differences in Theory of Mind development due to limited access to spoken language and incidental learning. Assessing their social cognitive abilities requires tailored tools that accommodate their unique communication modes. This study aims to evaluate the adaptability and validity of a questionnaire designed to assess social cognition in deaf children aged 3 to 6 with cochlear implants. By analyzing communication strategies, response variability, and social interaction patterns, the research seeks to refine assessment methods, ensuring they accurately capture these children's cognitive and social competencies.
- The content of the responses: it is essential to measure this because it enables us to assess the quality of the children's reflections. Response content provides valuable insights into how deaf children with cochlear implants before 15 months perceive and interpret social interactions. This will allow us to test whether deaf children develop similar or different strategies for understanding the social world. Rich and relevant content would indicate good integration of social skills, which would be an indicator of success for the study.
- Understanding their own answers: it is important to check that the children understand what they are answering. This criterion is important because it ensures that the answers given are not the result of chance or a desirability bias, but of genuine reflection and a real understanding of social concepts. A child's understanding of his or her own responses is indicative of cognitive maturity and the ability to apply knowledge in social contexts, which is a central objective of the study.
- The degree of response, the completeness and accuracy of the answers given, is a key indicator of children's ability to understand and engage in cognitive tasks. This criterion measures the commitment and mental effort invested by the child in the exercise, as well as his or her ability to formulate detailed and relevant answers. A high level of response would be a positive sign of successful cochlear implantation in terms of cognitive and social development, while a low level of response could suggest difficulties in processing social information or expressing thoughts coherently.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| deaf child with a cochlear implant | – | Other: Questionnaire comprehension testThis study focuses on children aged 3 to 6 years with congenital severe-to-profound deafness who received a cochlear implant before 15 months of age. The research aims to assess the adaptability of a standardized questionnaire evaluating social cognition in this population. Their communication abilities, response variability, and social interaction patterns are analyzed to refine assessment tools. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of children aged 3 to 6 years with congenital severe-to-profound deafness who received a cochlear implant before 15 months of age.
Key inclusion criteria (4 listed)
- Children aged 3 to 6 years old, who received a cochlear implant before the age of 15 months, who use their implant(s) and have a supportive family environment,
- Children with at least one cochlear implant undergoing speech therapy and are being monitored by the Pediatric Cochlear Implant Unit at Toulouse University Hospital,
- Children who are able to communicate: through speech, gestures, or French Sign Language,
- Children and their family whose mother tongue is French, - Social security coverage.
Key exclusion criteria (4 listed)
- Cognitive or psychological impairment preventing the child from communicating,
- Other sensory or motor deficits that may interfere with pointing,
- Unstable psychiatric illness,
- Child whose parents both benefit from a legal protection measure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire comprehension testParticipants will complete a standardized questionnaire assessing social cognition, adapted for cochlear-implanted children aged 3 to 6 years. The assessment includes the Item Scale and the Test of Emotions Comprehension adapted and mixed together. The questionnaire evaluates children's ability to understand emotions, social interactions, and cognitive perspective-taking. Each child will complete the test in a single session lasting approximately 20 minutes, under the supervision of a trained investigator, with an orthophonist and a parent present | Other | deaf child with a cochlear implant |
Primary outcome
Completion Rate of Standardized Social Cognition Questionnaire
Time frame: Assessed during a single study visit (approximately 20-minute session).
The primary outcome measure is the proportion of children who successfully complete all items of the standardized social cognition questionnaire. Success is determined by the child's ability to understand and respond coherently to the questions, demonstrating engagement and cognitive processing related to social interactions and emotions.
4 secondary outcomes
Communication Ability During Questionnaire Completion
Time frame: Assessed during a single study visit (approximately 20-minute session)
Variability of Responses Among Participants
Time frame: Assessed during a single study visit (approximately 20-minute session).
Homogeneity of Responses Within the Study Group
Time frame: Assessed during a single study visit (approximately 20-minute session).
Identification of Social Skills Demonstrated During the Assessment
Time frame: Assessed during a single study visit (approximately 20-minute session).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Background: PubMed 23084781Fulcher A, Purcell AA, Baker E, Munro N. Listen up: children with early identified hearing loss achieve age-appropriate speech/language outcomes by 3 years-of-age. Int J Pediatr Otorhinolaryngol. 2012 Dec;76(12):1785-94. doi: 10.1016/j.ijporl.2012.09.001. Epub 2012 Oct 17.
- Background: PubMed 24466572De Giacomo A, Craig F, D'Elia A, Giagnotti F, Matera E, Quaranta N. Children with cochlear implants: cognitive skills, adaptive behaviors, social and emotional skills. Int J Pediatr Otorhinolaryngol. 2013 Dec;77(12):1975-9. doi: 10.1016/j.ijporl.2013.09.015.
- Background: PubMed 9831147Allen MC, Nikolopoulos TP, O'Donoghue GM. Speech intelligibility in children after cochlear implantation. Am J Otol. 1998 Nov;19(6):742-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deaf Children and Cochlear Implant, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Noelle Calmels (+33 (0)5 61 77 90 09, calmels.mn@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rate of Standardized Social Cognition Questionnaire (time frame: Assessed during a single study visit (approximately 20-minute session).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06914531, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.